ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy

Recruiting now · Phase 1/Phase 2

Conditions studied: BAG3 Mutation Associated Dilated Cardiomyopathy

In brief

This Phase 1/2 study is an open-label, dose finding and dose expansion study investigating the safety, tolerability, and efficacy of a single IV infusion of ALXN2350 in adult participants with BAG3 associated DCM.

Key facts

Study ID

NCT07218887

Run by

Alexion Pharmaceuticals, Inc.

People needed

6

Starts

2025-10-24

Expected to finish

2032-01-27

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathogenic or likely pathogenic mutation in BAG3
• Medical history of diagnosis of DCM
• Stable combination of HF SoC medications
• Adequate acoustic windows for echocardiography

You may not qualify if…

• Presence of antibodies to AAV9
• Presence of a pathogenic or likely pathogenic variant in another gene where that other gene is authoritatively recognized as causal for DCM.
• Decompensated HF
• Note: Other inclusion and exclusion criteria may apply.

Where it is running

• Research Site — Birmingham, Alabama, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Cincinnati, Ohio, United States (enrolling)
• Research Site — Portland, Oregon, United States (enrolling)
• Research Site — Philadelphia, Pennsylvania, United States (enrolling)
• Research Site — Houston, Texas, United States (enrolling)
• Research Site — Massa, Italy (enrolling)
• Research Site — Barcelona, Spain (enrolling)
• Research Site — Majadahonda, Spain (enrolling)
• Research Site — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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